Autologous cultured chondrocytes - Biologic Drug Details

Summary for autologous cultured chondrocytes

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
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Recent Clinical Trials for autologous cultured chondrocytes

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Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for autologous cultured chondrocytes Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for autologous cultured chondrocytes Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for autologous cultured chondrocytes Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Autologous Cultured Chondrocytes

Introduction

Autologous cultured chondrocytes, a key component in cartilage repair and regeneration, have been gaining significant attention in the medical and biotechnology sectors. This article delves into the market dynamics, financial trajectory, and the evolving landscape of this biologic drug.

Market Size and Growth

The global market for knee cartilage repair, which includes autologous cultured chondrocytes, is projected to reach $5.9 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.3% over the forecast period. This growth is driven by the increasing preference for minimally invasive surgeries and advanced cartilage regeneration techniques[1].

Key Procedures and Technologies

Autologous Chondrocyte Implantation (ACI)

ACI is a prominent procedure in cartilage repair, involving the culturing of a patient's own chondrocytes to repair cartilage defects. The autologous chondrocyte implantation segment is expected to grow at the highest rate during the forecast period due to its growing preference, short recovery time, and easy availability[1].

Matrix-Induced Autologous Chondrocyte Implantation (MACI)

MACI is a next-generation method of ACI, which uses a biodegradable matrix to deliver cultured chondrocytes. MACI offers several advantages, including a simpler and less invasive procedure, reduced surgical time, and improved post-operative outcomes. MACI has replaced older ACI methods like Carticel and is currently the only FDA-approved ACI therapy on the market[4].

Other Cartilage Regeneration Approaches

Other modern approaches include autologous matrix-induced chondrogenesis (AMIC) and single-stage techniques designed to reduce the cost and morbidity associated with traditional ACI procedures. These advancements are continually shaping the market landscape[1].

Financial Performance of Key Players

Vericel Corporation

Vericel, a leading player in the field, reports significant financial growth driven by its products MACI and Epicel. In 2020, Vericel's total net revenue increased by 5% to $124.2 million, with MACI contributing $94.4 million and Epicel contributing $27.5 million. The company also reported a gross margin of 68% and a net income of $2.9 million for the year ended December 31, 2020[3].

Aastrom Biosciences (Now Part of Vericel)

Aastrom Biosciences, which acquired the cell therapy and regenerative medicine business of Sanofi in 2014, played a crucial role in the market. The acquired business included products like Carticel, Epicel, and MACI. Despite initial operational challenges, Aastrom implemented strategic initiatives to reduce costs and improve efficiencies, aiming to generate positive cash flow and accretive growth[2].

Geographic Market Distribution

The global market for knee cartilage repair is segmented geographically into North America, Europe, Asia Pacific, Latin America, and the Rest of the World. North America and Europe are significant markets due to advanced healthcare infrastructure and higher adoption rates of new technologies[1].

Clinical and Cost-Effectiveness

The clinical effectiveness of autologous chondrocyte implantation (ACI) has been studied in various trials. While ACI shows better results than mosaicplasty and microfracture in some studies, there is insufficient evidence to conclude its cost-effectiveness compared to these alternatives. Long-term outcomes and further research are needed to fully assess its economic viability[5].

Regulatory Environment

The FDA has approved Carticel for the repair of symptomatic cartilaginous defects, but it was later replaced by MACI. MACI is the only current FDA-approved ACI therapy, highlighting the stringent regulatory environment and the need for continuous innovation and clinical validation[4].

Future Outlook

The future of autologous cultured chondrocytes looks promising, driven by advancements in technology and increasing demand for minimally invasive cartilage repair procedures. The market is expected to continue growing as more efficient and cost-effective methods are developed.

Emerging Trends

• Single-Stage Techniques: Designed to reduce the morbidity and cost associated with traditional ACI procedures.
• Advanced Biomaterials: Third-generation ACI products are being engineered to deliver biofactors and induce favorable chondrogenic responses.
• Global Expansion: The market is expanding into new regions, particularly in Asia Pacific, where there is a growing need for advanced cartilage repair solutions[1][4].

Key Takeaways

• The global market for knee cartilage repair is projected to reach $5.9 billion by 2031.
• Autologous chondrocyte implantation (ACI) and MACI are key drivers of market growth.
• Vericel Corporation is a leading player with significant financial growth from its MACI and Epicel products.
• The market is geographically diverse, with North America and Europe being major contributors.
• Clinical and cost-effectiveness studies are ongoing, with a need for longer-term outcomes.
• Regulatory approvals are crucial, with MACI being the only current FDA-approved ACI therapy.

FAQs

What is the projected market size for knee cartilage repair by 2031?

The global market for knee cartilage repair is expected to reach $5.9 billion by 2031, growing at a CAGR of 7.3%[1].

What are the key procedures in cartilage repair using autologous cultured chondrocytes?

Key procedures include Autologous Chondrocyte Implantation (ACI) and Matrix-Induced Autologous Chondrocyte Implantation (MACI)[1][4].

Which company is a leading player in the market for autologous cultured chondrocytes?

Vericel Corporation is a leading player, with significant revenue from its MACI and Epicel products[3].

What are the main geographic markets for knee cartilage repair?

The main geographic markets include North America, Europe, Asia Pacific, Latin America, and the Rest of the World[1].

Is autologous chondrocyte implantation (ACI) cost-effective compared to other methods?

There is currently insufficient evidence to conclude that ACI is cost-effective compared to methods like microfracture or mosaicplasty. Longer-term outcomes are needed[5].

What are the regulatory approvals for MACI?

MACI is the only current FDA-approved ACI therapy, approved for the repair of symptomatic cartilaginous defects[4].

Sources

1. Global Knee Cartilage Repair Market: iHealthcareAnalyst
2. Aastrom Announces Strategic Plan for Recently Acquired Cell Therapy: Aastrom Biosciences
3. Vericel Reports Fourth Quarter and Full-Year 2020 Financial Results: Biospace
4. Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions: Beonbrand
5. Clinical and Cost-Effectiveness of Autologous Chondrocyte Implantation: PubMed

Last updated: 2024-12-18